Prophylactic Administration of Fibrinogen Concentrate in Perioperative Period of Total Hip Arthroplasty: a Randomized Clinical Trial Study
-
Atabak Najafi
,
Reza Shariat Moharari
,
Amir Ali Orandi
,
Farhad Etezadi
,
Mehdi Sanatkar
,
Mohammad Reza Khajavi
,
Arezoo Ahmadi
,
Pejman Pourfakhr
,
Farsad Imani
,
Mojtaba Mojtahedzadeh
,
Amir Hossein Orandi
Abstract
According to limitations in blood product resources and to prevent unnecessary transfusions and afterwards complications in perioperative period of total hip arthroplasty, authors administered fibrinogen concentrate in a pilot randomized clinical trial to evaluate bleeding and need to blood transfusion in preoperative period. Thirty patients (3-75 years old) with ASA physical status class I or II and candidate for total hip arthroplasty consequently enrolled in this study and randomly assigned into two groups: taking fibrinogen concentrate and control. Two groups were similar in serum concentration of fibrinogen, hemoglobin, and platelet preoperatively. After induction of general anesthesia 30 mg/kg fibrinogen concentrate was administered in the fibrinogen group. Blood loss, need to blood transfusion and probable complications were compared between two groups. The mean operation time was 3.3 ± 0.8 hours in the fibrinogen group and 2.8 ± 0.6 hours in the placebo group, and this difference was statistically significant (P=0.04). There was a significant correlation between operation time and blood loss during surgery (P=0.002). The mean transfused blood products in the fibrinogen and control group was 0.8 ± 1.01 units and 1.06 ± 1.2 units respectively (P=0.53). The mean of perioperative blood loss was 976 ± 553 ml in the fibrinogen group and 1100 ± 350 ml in the control group, but this difference was not significant between two groups. By adjusting time factor for two groups, we identified that the patients in fibrinogen group had lower perioperative bleeding after adjusting time factor for two groups (P=0.046). None of the patients had complications related to fibrinogen concentrate administration. The prophylactic administration of fibrinogen concentrate was safe and effective in reducing bleeding in the perioperative period of total hip arthroplasty.
Key NS, Negrier C. Coagulation factor, concentrates past, present, and future. Lancet 2007;370(9585):439-48.
Erber WN, Perry DJ. Plasma and plasma products in the treatment of massive haemorrhage. Best Pract Res Clin Haematol 2006;19(1):97-112.
Stainsby D, MacLennan S, Thomas D, et al. Guidelines on the management of massive blood loss. Br J Haematol 2006;135(5):634-41.
Koch CG, Li L, Duncan AI, et al. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Crit Care Med 2006;34(6):1608-16.
Murad MH, Stubbs JR, Gandhi MJ, et al. The effect of plasma transfusion on morbidity and mortality: A systematic review and metaanalysis. Transfusion 2010;50(6):1370-83.
Murphy GJ, Reeves BC, Rogers CA, et al. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation 2007;116(22):2544-52.
Surgenor SD, Kramer RS, Olmstead EM, et al. The association of perioperative red blood cell transfusions and decreased long-term survival after cardiac surgery. Anesth Analg 2009;108(6):1741-6.
Vivacqua A, Koch CG, Yousuf AM, et al. Morbidity of bleeding after cardiac surgery: Is it blood transfusion, reoperation for bleeding, or both? Ann Thorac Surg 2011;91(6):1780-90.
Dempfle CE, Kälsch T, Elmas E, et al. Impact of fibrinogen concentration in severely ill patients on mechanical properties of whole blood clots. Blood Coagul Fibrinolysis 2008;19(8):765-70.
Rahe-Meyer N, Pichlmaier M, Haverich A, et al. Bleeding management with fibrinogen concentrate targeting a highnormal plasma fibrinogen level: a pilot study. Br J Anaesth 2009;102(6):785-92.
Miller RD, editor. Miller’s Anesthesia. 7th ed. Philadelphia: Churhill Livingstone; 2009: p. 2248.
Jakobsen CJ, Ryhammer PK, Tang M, et al. Transfusion of blood during cardiac surgery is associated with higher long-term mortality in low-risk patients. Eur J Cardiothoracic Surg 2012;42(1):114-20
British Committee for Standards in Haematology, Stainsby D, MacLennan S, et al. Guidelines in the management of massive blood loss. Br J Haematol 2006;135(5):634-41.
Diaz-Martin A, Escoresca-Ortega AM, Hernandez- Caballero C, et al. Considerations regarding major bleeding after cardiac transplantation. Transplant Proc 2010;42(8):3204-5.
Fenger-Eriksen C, Ingerslev J, Sørensen B. Fibrinogen concentrate–a potential universal hemostatic agent. Expert Opin Biol Ther 2009;9(10):1325-33.
Lang T, Johanning K, Merzler H, et al. The effects of fibrinogen levels on Thromboelastometric variables in the presence of thrombocytopenia. Anesth Analg 2009;108(3):751-8.
Bolliger D,Szlam F, Molinaro RJ, et al. Finding the optimal concentration range for fibrinogen replacement after severe haemodilution: an in vitro model. Br J Anaesth 2009;102(6):793-9
Haas T, Fries D, Velik-Salchner C, et al. The in vitro effects of fibrinogen concentrate, factor XIII and fresh frozen plasma on impaired clot formation after 60% dilution. Anesth Analg 2008;106(5):1360-5.
Martini WZ, Chinkes DL, Pusateri AE, et al. Acute changes in fibrinogen metabolism and coagulation after hemorrhage in pigs. Am J Physiol Endocrinol Metab 2005;289(5):E930-4.
Velic Salchner C, Haas T, Innerhofer P, et al. The effect of fibrinogen concentrate on thrombocytopenia. J Thromb Haemost 2007;5(5):1019-25.
Fenger-Eriksen C, Lindberg-Larsen M, Christensen AQ, et al. Fibrinogen concentrate substitution therapy in patients with massive haemorrhage and low plasma fibrinogen concentrations. Br J Anaesth 2008;10(6):769-73.
Stinger HK, Spinella PC, Perkins JG, et al. The ratio of fibrinogen to red cells transfused affects survival in casualties receiving massive transfusions at an army combat support hospital. J Trauma 2008;64(2 Suppl):S79-85.
Fenger-Eriksen C, Jensen TM, Kristensen BS, et al. Fibrinogen substitution improves whole blood clot firmness after dilution with hydroxyethyl starch in bleeding patients undergoing. J Thromb Haemost 2009;7(5):795-802.
Mittermayr M, Streif W, Haas T, et al. Hemostatic changes after crystalloid or colloid fluid administration during major orthopedic surgery: the role of fibrinogen administration. Anesth Analg 2007;105(4):905-17.
Solomon C, Pichlmaier U, Schoechl H et al. Recovery of fibrinogen after administration of fibrinogen concentrate to patients with severe bleeding after cardiopulmonary bypass surgery. Br J Anaesth 2010;104(5):555-62.
Rahe-Meyer N, Pichlmaier M, Haverich A, et al. Bleeding management with fibrinogen concentrate targeting a highnormal plasma fibrinogen level: a pilot study. Br J Anaesth 2009;102(6):785-92.
Karlsson M, Ternstrom L, Hyllner M, et al. Prophylactic fibrinogen infusion reduces bleeding after coronary artery bypass surgery: A prospective randomised pilot study. Thromb Haemost 2009;102(1):137-44.
Rahe-Meyer N, Solomon C, Winterhalter M, et al. Treatment of excessive intraoperative bleeding in thoracoabdominal aortic aneurysm surgery with fibrinogen concentrate. J Thorac Cardiovasc Surg 2009;138(3):694-702.
Solomon C, Rahe-Meyer N, Sørensen B. Fibrin formation is more impaired than thrombin generation and platelets immediately following cardiac surgery. Thromb Res 2011;128(3):277-82.
Blome M, Isgro F, Kiessling AH, et al. Relationship between factor XIII activity, fibrinogen, haemostasis screening tests and postoperative bleeding in cardiopulmonary bypass surgery. Thromb Haemost 2005;93(6):1101-7.
Görlinger K, Dirkmann D, Hanke AA, et al. First-line therapy with coagulation factor concentrates combined with pointof-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: A retrospective, single-center cohort study. Anesthesiology 2011;115(6):1179-91.
Karlsson M, Ternström L, Hyllner M, et al. Prophylactic fibrinogen infusion reduces bleeding after coronary artery bypass surgery. A prospective randomized pilot study. Thromb Haemost 2009;102(1):137-44.
Dickneite G, Pragst I, Joch C, et al. Animal model and clinical evidence indicating low thrombogenic potential of fibrinogen concentrate (Haemocomplettan P). Blood Coagul Fibrinolysis 2009;20(7):535-40.
Manco-Johnson MJ, Dimichele D, Castaman G, et al. Fibrinogen Concentrate Study Group: Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost 2009;7(12):2064-9.
Ketchum L, Hess JR, Hiippala S. Indications for early fresh frozen plasma, cryoprecipitate, and platelet transfusion in trauma. J Trauma 2006;60(6 Suppl):S51-8.
American Society of Anesthesiologists Task Force on Peri operative Blood Transfusion and Adjuvant Therapies.Pract ice Guidelines for Perioperative Blood Transfusion and Adjuvant Therapies: An updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Anesthesiology 2006;105(1):198-208.
Ciavarella D, Reed RL, Counts RB, et al. Clotting factor levels and the risk of diffuse microvascular bleeding in the massively transfused patient. Br J Haematol 1987;67(3):365-8.
| Files | ||
| Issue | Vol 52, No 11 (2014) | |
| Section | Original Article(s) | |
| Keywords | ||
| Fibrinogen Bleeding Coagulation Total hip arthroplasty | ||
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